Advancing Non-Abstinence Outcomes in the Treatment of Methamphetamine Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Mean Arterial Pressure
研究概览
简要总结
Reduced drug use is a clinically meaningful target for treatment development, but few studies have evaluated the positive impacts produced by this behavioral change, preventing adoption of this endpoint in clinical trials. The proposed research will fill that critical knowledge gap by demonstrating the biopsychosocial benefits of reduced methamphetamine use. These data will be used to change current accepted methamphetamine treatment endpoints and accelerate identification of therapies for methamphetamine use disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be age 18 years or older;
- •self-report methamphetamine use in the week prior to screening;
- •provide a methamphetamine-positive urine sample at screening;
- •meet DSM-5 criteria for moderate-severe Methamphetamine Use Disorder (MUD);
- •be seeking treatment for their methamphetamine use
- •be able and willing to commit to the 12-week intervention, as well as the 12-week post-intervention follow-up
- •Individuals who meet these criteria and are stably maintained on buprenorphine or methadone for Opioid Use Disorder (OUD) will also be eligible to participate.
排除标准
- •current or past medical or psychiatric illness (e.g., physical dependence on any drug other than buprenorphine requiring medically managed detoxification, unstable angina, uncontrolled cardiac arrhythmia, aortic stenosis, self-reported compromised immune function, severe diagnosis for a SUD other than MUD or treated OUD) that would interfere with study participation in the opinion of the study physicians
- •poor venous access precluding blood draws
研究组 & 干预措施
Control Group
This group will receive payment for providing urine samples throughout the trial.
Contingency Management Group
This group will receive payment for providing methamphetamine negative urine samples throughout the trial.
干预措施: Contingency Management (Behavioral)
结局指标
主要结局
Mean Arterial Pressure
时间窗: Week 12 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Endothelin-1
时间窗: Week 12 of participation.
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Mean Arterial Pressure
时间窗: At baseline.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
时间窗: Week 1 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
时间窗: Week 2 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
时间窗: Week 3 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
时间窗: Week 4 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
时间窗: Week 5 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
时间窗: Week 6 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
时间窗: Week 7 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
时间窗: Week 8 of participation.
Mean Arterial Pressure was recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
时间窗: Week 9 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
时间窗: Week 10 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Mean Arterial Pressure
时间窗: Week 11 of participation.
Mean Arterial Pressure is recorded during subject visits and is recorded in mm Hg
Endothelin-1
时间窗: At baseline.
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
Endothelin-1
时间窗: Week 6 of participation.
Endothelin-1 levels will be measured. They will be recorded in pg/ml.
次要结局
- Sleep(Week 12 of participation.)
- Sleep(At baseline.)
- Sleep(Week 4 of participation.)
- Sleep(Week 8 of participation.)
研究者
William Stoops
Professor
University of Kentucky